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LASERMEDICS EXPECTS TO FILE WITH FDA BY EARLY FALL

 STAFFORD, Texas, May 13 /PRNewswire/ -- Lasermedics, Inc. (NASDAQ: LMDX) announces that it recently had its annual on-site inspection conducted by the FDA. The company said that it received written comments requiring Lasermedics to establish and maintain a complaint file and a warranty repair file for the company's product, the MicroLight 830 "cold" laser, as well as "list" and "register" the device. The company's response includes a registration filing and a device listing with the FDA. Also included was a complete customer complaint and warranty response protocol. In addition, Lasermedics has filed the initial laser report regarding the MicroLight 830 with the FDA.
 The company said it is consulting a voluntary recall of 17 investigational lasers that are not currently being used in connection with an approved Institutional Review Board (IRB), and that there are no safety or health issues related to the recall. Lasermedics said it does not believe the recall will have any material adverse effect on its financial statements.
 The company also said it has selected Michael Heitmann, DVM with the Katy Equine Center, one of the premier large animal clinics in South Texas, to evaluate the MicroLight 830 in the treatment of check ligament inflation in horses. Check ligament in horses is analogous to repetitive stress injuries in humans.
 Lasermedics said that it expects to present its 510K to the FDA sometime in the early fall.
 -0- 5/13/93
 /CONTACT: Michael Barbour, president of Lasermedics, Inc., 713-261-5079, or Edward Williamson of Williamson & Associates, 800-992-6616, for Lasermedics, Inc./
 (LMDX)


CO: Lasermedics, Inc. ST: Texas IN: MTC SU:

SH-SM -- NY025 -- 7982 05/13/93 09:55 EDT
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Publication:PR Newswire
Date:May 13, 1993
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